Tissue marking device and methods of use thereof

ABSTRACT

Disclosed herein are tissue marking devices and methods that enables marking a target tissue more than 24 hours prior to surgery. The tissue marking device includes a hook assembly having a compressed configuration and a deployed configuration and a handle assembly for positioning the hook assembly in a targeted tissue. The hook assembly may include a hook body comprising at least two hooks and a thread connected to the hook body. The handle assembly may include a handle body, a needle having a lumen, and a stylet having a lumen.

CROSS-REFERENCE TO RELATED PATENT APPLICATION

This patent application claims the benefit under 35 U.S.C. § 119(e) ofU.S. Patent Application Ser. No. 62/746,922, entitled “TISSUE MARKINGDEVICE AND METHODS OF USE THEREOF,” filed on Oct. 17, 2018, which isincorporated herein by reference in its entirety.

FIELD OF THE INVENTION

The present invention relates generally to surgical tissueidentification and removal, and more specifically, to a marking specifictissues within a breast at a time prior to removal of the tissue bysurgery.

BACKGROUND

Tissue marking is used to externally indicate to a surgeon which tissueis to be tracked or removed, such as a tumor or mass. For example, aftera breast biopsy determining that a tissue is cancerous and needs to beremoved, a tissue marking device with a single hook attached to a rigidwire is inserted such that the wire extends outside the breast. Thetissue marking device provides an external indication of the location ofthe tumor for the surgeon.

However, the standard tissue marking device has many limitations. Usingcurrent technology, the tissue must be marked on the same day, justprior to surgery to avoid displacing the hook. This leads to an extendedtime that the patient must be at the hospital. Coordinating schedules ofRadiology, Surgery, and the Operating room staff leads to inefficienciesand affects patient satisfaction.

Accordingly, there is a need for a tissue marking device that is notprone to movement once in place such that it may be placed in a patientmore than 24 hours before a surgery to remove the tissue.

BRIEF SUMMARY

The disclosure provides for a tissue marking device and methods ofmarking a tissue. The tissue marking device may include a hook assemblyhaving a compressed configuration and a deployed configuration and ahandle assembly for positioning the hook assembly in a targeted tissue.In an aspect, the hook assembly may include a hook body comprising atleast two hooks, a retention mechanism, and a thread connected to thehook body. In one aspect, a metal thread may be welded, crimped,swagged, kinked, UV bounded, laser welded, or joined by any of meanssuitable for bonding metals to the proximal end of the hook body to formthe hook assembly. In another aspect, the handle assembly may include ahandle body having a proximal end and a distal end, a plunger having alocking mechanism, a needle having a lumen with an open first end and asecond end, and a stylet having a lumen with an open first end and asecond end. In an aspect, the hook body and the stylet are within thelumen of the needle and the thread is within the lumen of the styletwhen the hook assembly is in the compressed configuration.

Further provided herein is a method of marking a target tissue in apatient. In an aspect, the method may include inserting a needle of thetissue marking device into a patient, confirming the location of theneedle such that the hook body is near the target tissue, unlocking thelocking mechanism on the handle body, depressing the plunger to extendthe hook body past the needle and open the at least two hooks andretention mechanism to embed the hook body in the target tissue, andremoving the needle and the stylet from the patient.

In another aspect, the method of marking a target tissue in a patientmay include implanting a hook assembly of a tissue marking device into atarget tissue of a patient. In this aspect, the hook assembly isoperable to absorb compression without migrating more than 1 cm withinthe target tissue. In another aspect, the hook assembly is operable toallow the patient to have surgery to remove the hook assembly on aseparate day from implantation.

Additional aspects and features are set forth in part in the descriptionthat follows, and will become apparent to those skilled in the art uponexamination of the specification or may be learned by the practice ofthe disclosed subject matter. A further understanding of the nature andadvantages of the disclosure may be realized by reference to theremaining portions of the specification and the drawings, which forms apart of this disclosure.

DESCRIPTION OF THE DRAWINGS

The description will be more fully understood with reference to thefollowing figures, which are presented as variations of the disclosureand should not be construed as a complete recitation of the scope of thedisclosure, wherein:

FIG. 1A is a perspective view of the tissue marking device in onevariation.

FIG. 1B is a perspective view of the tissue marking device in onevariation.

FIG. 2A is a view of the distal end of the tissue marking device withthe hook body in the compressed configuration as it would be seen ifinside the needle, in one variation.

FIG. 2B is a view of the hook body in the compressed configuration as itwould be seen if inside the needle, in one variation.

FIG. 2C is a view of the distal end of the tissue marking device withthe hook assembly in the deployed configuration, in one variation.

FIG. 2D is a view of the distal end of the tissue marking device withthe hook assembly in the deployed configuration, in one variation.

FIG. 3A is a side view of a non-removable hook assembly with three hooksin one variation.

FIG. 3B is a side view of a hook assembly with three hooks in onevariation.

FIG. 3C is a side view of a hook assembly with two hooks in a 90°configuration in one variation.

FIG. 3D is a side view of a hook assembly with two hooks in a 180°configuration in one variation.

FIG. 3E is a side view of a hook assembly with two hooks in a 180°configuration and a retention mechanism with two proximal hooks in onevariation.

FIG. 3F is a side view of a hook assembly with two hooks in a 180°configuration and a retention mechanism with two proximal hooks in onevariation.

FIG. 4A is a side view of a handle assembly in the loaded position inone variation.

FIG. 4B is a side view of a handle assembly in the deployed position inone variation.

FIG. 4C is a side view of a handle body in one variation.

FIG. 4D is a side view of a plunger in one variation.

FIG. 4E is a side view of a handle assembly in the deployed position inone variation.

FIG. 5 is a diagram of a method of using of the tissue marking device inone variation.

FIG. 6 is a diagram of a method of using of marking a target tissue inone variation.

DETAILED DESCRIPTION

The tissue marking device and method of use will be understood, both asto its structure and operation, from the accompanying drawings, taken inconjunction with the accompanying description. It is noted that, forpurposes of illustrative clarity, certain elements in various drawingsmay not be drawn to scale. Several variations of the device arepresented herein. It should be understood that various components,parts, and features of the different variations may be combined togetherand/or interchanged with one another, all of which are within the scopeof the present application, even though not all variations andparticular variations are shown in the drawings. It should also beunderstood that the mixing and matching of features, elements, and/orfunctions between various variations is expressly contemplated herein sothat one of ordinary skill in the art would appreciate from thisdisclosure that the features, elements, and/or functions of onevariation may be incorporated into another variation as appropriate,unless described otherwise.

For purposes of this description, “distal” refers to the end extendinginto a body and “proximal” refers to the end extending out of the body.

For purposes of this description “connected to” includes two componentsbeing directly connected or indirectly connected with interveningcomponents.

The terms used in this specification generally have their ordinarymeanings in the art, within the context of the disclosure, and in thespecific context where each term is used. Alternative language andsynonyms may be used for any one or more of the terms discussed herein,and no special significance should be placed upon whether or not a termis elaborated or discussed herein. In some cases, synonyms for certainterms are provided. A recital of one or more synonyms does not excludethe use of other synonyms. The use of examples anywhere in thisspecification including examples of any terms discussed herein isillustrative only, and is not intended to further limit the scope andmeaning of the disclosure or of any example term.

In traditional lumpectomy procedures, a localization wire is placed by aradiologist on the same day of the surgical procedure. This protocolrequires the patient to go through two procedures in two separatedepartments on the same day. For the patient, this leads to increasedanxiety levels and a reduction in satisfaction. For the facility, thiscan lead to lost revenue from scheduling difficulties. Wire-basedlocalization technologies are also mechanically deficient. Wires canmove during the long procedure day and are uncomfortable and awkward forthe patient. It is not possible to schedule the radiological andsurgical procedures on separate days using wire-based localization.

Capital equipment technologies require the use of expensive equipment(i.e. capital) to separate the procedure days. For example, thesecapital equipment systems use expensive technology like radar ormagnets, combined with an external hardware system to localize thelesion. These technologies are expensive and have barriers to entry forthe user. The facility must absorb the cost of the capital component toimplement the technology and the cost of the actual treatment materialsexceeds the available reimbursement. There is currently no simple,“low-cost” and/or single-use solution for breast lesion localization tobe treated on a separate day from surgery.

The disclosed tissue marking device and methods of use thereof providesfor the rapid marking of tissue more than 24 hours prior to the surgery.The tissue marking device provides a “low-cost” and single-usealternative to capital equipment technologies and provides for theseparation of treatment days as an alternative to wire-basedlocalization. For example, the tissue marking device uses a hookassembly with superior pull force strength to minimize migration andabsorb compression and uses a flexible thread instead of a wire. Inparticular, the hook assembly is operable to absorb compression withoutmigrating more than 1 cm within the target tissue. These features,described in detail below, allow for the device to be placed on aseparate day than the surgery to remove the target tissue. In addition,the tissue marking device allows the patient to move without discomfortor risk of dislocating the hook marking the target tissue. Moreover, thetissue marking device is a simple, easy to use, handheld device formarking target tissue and does not require investment of any expensiveequipment such as radar or magnets. The tissue marking device is aneconomically effective solution for the clinical, scheduling, andpatient satisfaction issues associated with the current standard. Insome variations, the tissue marking device overcomes one or more of theabove-listed problems commonly associated with conventional wire markerdevices and capital equipment technologies.

FIG. 1 depicts a side view of a tissue marking device for marking atarget tissue in one variation. In various variations the target tissuemay be within a breast. Examples of target tissue include lesions,cancerous and non-cancerous tumors, or masses.

As seen in FIGS. 1A-1B, the tissue marking device 100 includes a handleassembly 110 and a hook assembly 105. In a variation, the handleassembly 110 includes a handle body 111, a needle 106, and a stylet 108.The hook assembly 105 includes a hook body 102 connected to a thread104. The handle assembly 110 is used insert and deploy the hook assembly105 at the target tissue and allow for easy removal of the handleassembly 110 once the hook assembly 105 is deployed. The hook assemblyremains in the patient, with the hook body 102 located at the targettissue and the thread 104 extending from the hook body to outside thepatient's body. In a variation, the thread 104 may be flexible such thatit can remain external to the body more than 24 before surgery withoutrisking migration of the hook body 102 if the thread 104 is touched bythe patient. In another variation, the hooks 101 on the hook body 102may prevent unintended migration of the hook body 102 after the hookassembly 105 has been placed and deployed.

The hook assembly 105, by way of the hook body 102, can be in acompressed configuration or a deployed configuration. In the compressedconfiguration, the hooks 101 and/or retention mechanism 107 of the hookbody 102 are compressed together such that the hook assembly 105 can beloaded and fit within the lumen of the needle 106. For example, the hookbody 102 in the compressed configuration generally looks like a tube. Ina variation, the hooks 101 and/or retention mechanism 107 of the hookbody 102 are forcibly compressed by the lumen of the needle 106. FIGS.2A-2B show the hook body 102 in the compressed configuration, in somevariations, as it would be seen if fully contained within the needle 106of the handle assembly 110. Once the handle assembly 110 pushes thestylet 108, the stylet 108 pushes the hook body 102 out of the needle106 and the hooks 101 and/or retention mechanism 107 expand or deploybecause they are no longer compressed by the needle 106. FIGS. 2C-2Dshow the hook body 102 in the deployed configuration, in somevariations, prior to the handle assembly 110 being removed.

The hook body 102 has a proximal end and a distal end. The hook body 102may include at least two hooks 101 at the distal end of the hook body102. FIGS. 3A-3F show non-limiting examples of distal hook shapes,numbers, and configurations that may be included on the hook body. In avariation, the at least two hooks 101 may be separated by 180°. In avariation, the at least two hooks 101 may be separated by 120°. In avariation, the at least two hooks 101 may be separated by 90°. In avariation, the at least two hooks 101 may be separated by 45°. In avariation, the at least two hooks 101 may be separated by a combinationof 180°, 120°, 90° and/or 45°. In some variations, the at least twohooks 101 may be equidistant from one another.

In some variations, the hook body may include at least two hooks 101. Insome variations, the hook body may include at least three hooks 101. Insome variations, the hook body may include at least four hooks 101. Insome variations, the hook body may include at least five hooks 101. In avariation, the hook body 102 may include three hooks 101, as seen inFIG. 3A or FIG. 3B. In a variation, two of the hooks may be separated by180° while a third hook may be 90° from each of the other two hooks. Ina variation, three hooks may be separated by 90° or 45°. In anothervariation, the hook body 102 may include two hooks, as seen in FIG. 3C,where the two hooks 101 are separated by 90°. In yet another variation,the hook body 102 may include two hooks, as seen in FIGS. 3D-3F, wherethe two hooks 101 are separated by 180°.

The at least two hooks 101 may have a straight configuration, a roundedconfiguration, a curved configuration, or any configuration sufficientto retain the hook body within the target tissue and absorb compressionforces. In a variation, the hooks 101 may have a rounded or curvedconfiguration, as seen in FIGS. 3E-3F. In a variation, the hooks 101 maybe offset from the hook body by about 45°. In a variation, the hooks 101may be offset from the hook body by about 90°. FIG. 3A is an example ofa hook body 102 with hooks 101 in a straight configuration and FIGS.3B-3D are examples of a hook body 102 with hooks 101 in a curvedconfiguration. In one variation, the hook body 102 may further include apointed distal end 103 extending past the hooks 101.

In a variation, the hook body may be non-removable. In other variations,the hook body may not be retracted, repositioned, or adjusted oncedeployed in the target tissue. In this variation, the hook assembly 105may not be removed from the body except through surgery. The handleassembly 110 may not be used to remove or replace the hook assembly 105.The hook body may not include any sharp ends that would otherwisefacilitate movement of the hook assembly within the tissue.

To aid in restricting migration of the hook assembly 105, the hook body102 may further include a retention mechanism 107 at the proximal end ofthe hook body 102, as seen in FIGS. 3E-3F. The retention mechanism mayprevent the hook body 102 or hook assembly 105 from retracting back intothe needle 106 once the hook assembly has been deployed. In addition,the retention mechanism may prevent the hook body 102 or hook assembly105 from migrating once the hook assembly has been deployed and thehandle assembly has been removed. This may allow the hook assembly 105to remain in the patient for an extended period of time, such that theplacement of the hook assembly may occur on a separate day from thesurgery to remove the target tissue.

The retention mechanism 107 may have any shape or structure that absorbscompression, facilitates retention of the hook assembly 105 within thetarget tissue, and prevents the hook body 102 from being retracted intothe needle 106 or migrating within the target tissue. In somevariations, the retention mechanism 107 may have a rounded hook shape,curved hook shape, a straight hook shape, an elbow shape, or a T-shape.In a variation, the retention mechanism 107 may include one proximalhook. In a variation, the retention mechanism 107 has a rounded orcurved hook shape, as seen in FIGS. 3E-3F. In a variation, the retentionmechanism 107 may include two proximal hooks. In a variation, theretention mechanism 107 may include three proximal hooks. In avariation, the retention mechanism 107 may include four proximal hooks.The retention mechanism 107 may be laser cut from the same nitinol tubethat the hooks are cut, such that the hooks, retention mechanism, andhook body are a single element. In a variation, the retention mechanism107 may be the same length as the hooks 101. In a variation, theretention mechanism 107 may be shorter than the hooks 101. In avariation, the retention mechanism 107 may be longer than the hooks 101.

In a variation, the hook body 102 may include two distal hooks 101 and aretention mechanism 107 with two proximal hooks, generally forming afour hook/arm configuration, or an “H” configuration, as seen in FIGS.3E-3F. In this variation, the hook body optimizes resistance tomigration while also allowing flex inside the tissue during normalpatient movements. In an example, the arms flex when compressed withnear zero migration. In a variation, the two distal hooks and the twoproximal hooks are located in the same plane. In another variation, thetwo distal hooks and the two proximal hooks are offset by an angle suchthat they are not in the same plane. For example, the anterior andposterior side of the hooks may help with compression from the top andbottom of the breast. In another variation, two 2D/planner elementscontaining one distal hook and one proximal hook may be heat set to thedesired bend radius and bonded together at the apex.

The hook body allows for the hook assembly to absorb compression forceswithout migrating a distance that would require re-localization byre-implantation of the hook assembly. In a variation, the hook assemblyis operable to allow the patient to have surgery to remove the hookassembly on a separate day from localization/implantation. The abilityto absorb compression forces may permit the patient to participate innormal activity between the time of localization/implantation of thehook assembly and the time of surgery to remove the target tissue.Non-limiting examples of normal activity include sleeping (face down ifdesired), rolling over, sexual activity, taking care of loved ones (forexample, kids), exercising, accidental bumping, and/or lifting heavingobjects.

The hook assembly 105, by way of the hook body 102, is operable toabsorb compression forces without migrating more than 1.5 cm from theoriginal placement within the target tissue. In a variation, the hookassembly is operable to absorb compression without migrating more than 1cm within the target tissue. In a variation, the hook assembly isoperable to absorb compression without migrating more than 8 mm withinthe target tissue. In a variation, the hook assembly is operable toabsorb compression without migrating more than 5 mm within the targettissue. In a variation, the hook assembly is operable to absorbcompression without migrating more than 3 mm within the target tissue.In a variation, the hook assembly is operable to absorb compressionwithout migrating more than 2 mm within the target tissue. In avariation, the hook assembly is operable to absorb compression withoutmigrating more than 1 mm within the target tissue. In a variation, thehook assembly is operable to absorb compression without migrating morethan 0.5 mm within the target tissue.

In a variation, the hook body 102 may have a length of 2 mm to 8 mm inthe compressed configuration. In a variation, the hook body has a lengthof at least 2 mm. In a variation, the hook body has a length of at least3 mm. In a variation, the hook body has a length of at least 4 mm. In avariation, the hook body has a length of at least 5 mm. In a variation,the hook body has a length of at least 7 mm. When in the compressedconfiguration, the hook body 102 has a diameter sufficient to fit withinthe lumen of a needle 106. In a variation, the hook body 102 may have adiameter of less than 1 mm in the compressed configuration. In avariation, each hook 101 may have a length of at least 1 mm. In avariation, each hook 101 may have a length of at least 2 mm. In avariation, each hook 101 may have a length of at least 3 mm. In avariation, each hook 101 may have a length of at least 4 mm. In avariation, each hook 101 may have a diameter of less than 1 mm. In avariation, each hook 101 may have a diameter of less than 1 mm. In avariation, each hook 101 may have a diameter of less than 0.75 mm. In avariation, each hook 101 may have a diameter of less than 0.5 mm. In avariation, the retention mechanism 107 may have a length of at least 1mm. In a variation, the retention mechanism 107 may have a length of atleast 3 mm.

In a variation, the hook body 102 may be formed from a tube that hasbeen laser cut to form the hooks 101. In this variation, the hooks 101and the hook body 102 are a single element. Therefore, the hooks 101 maybe integral to the hook body 102 and do not need to be attached togetheror attached to the hook body. This may allow the hook body 102 to takethe shape of a tube when in the compressed configuration. Without beinglimited to a particular theory, laser cutting the hooks 101 into thehook body 102 allows for the hook body 102 to have a compressedconfiguration in the shape of a tube and a deployed configuration withthe hooks 101 expanded, for example, as seen in FIGS. 2A and 2C. Thehooks 101 may be pre-formed in the deployed configuration and may needto be physically compressed to be in the compressed configuration, suchas being compressed by the lumen of the needle 106. In a variation, thehook body 102 may be formed from a nitinol tube.

In another variation, the hook body 102 may be formed from a tube thathas been laser cut to form the hooks 101 and retention mechanism 107. Inthis variation, the hooks 101, the retention mechanism 107, and the hookbody 102 are a single element. In some examples, the hooks 101 andretention mechanism 107 have the same shape, and may generally form fourhooks/arms cut from a single tube, as seen in FIG. 3E. Therefore, thehooks 101 and retention mechanism 107 may be integral to the hook body102 and do not need to be attached together or attached to the hookbody. This may allow the hook body 102 to take the shape of a tube whenin the compressed configuration. Without being limited to a particulartheory, laser cutting the hooks 101 and retention mechanism 107 into thehook body 102 allows for the hook body 102 to have a compressedconfiguration in the shape of a tube and a deployed configuration withthe hooks 101 and retention mechanism 107 expanded, for example, as seenin FIGS. 2B and 2D. The hooks 101 and retention mechanism 107 may bepre-formed in the deployed configuration and may need to be physicallycompressed to be in the compressed configuration, such as beingcompressed by the lumen of the needle 106. In a variation, the hook body102 with integral hooks 101 and retention mechanism 107, may be formedfrom a nitinol tube.

In a variation, the hook body 102 may include at least one radiopaquemarker. In some variations, the hooks 101 may include a radiopaquemarker. In other variations, the hook body 102 itself may be used as aradiopaque marker. It will be appreciated that the radiopaque markersmay be configured to communicate a set distance to further facilitatethe measurement of target tissue, to distinguish between multiple markedtissues, to demonstrate the distance of the hook from the targetedlesion, or indicate a distance from the hook body to a biopsy markerclip. It will be appreciated that any arrangement of radiopaque markersis contemplated.

The hook assembly 105 further includes a thread 104 connected to thehook body 102. The thread 104 may be connected to the hook body 102 suchthat it remains attached to the hook body 102 when the hook assembly 105is embedded in a targeted tissue. In some variations, the thread 104 maybe welded, crimped, swagged, kinked, UV bounded, laser welded, or joinedby any of means suitable for bonding metals onto the hook body 102.

The thread may be impervious to heat, completely flexible, resistant tocutting, provide a secure connection to the hook body, viewable onimaging, include marker bands, and have a proximal end that can besecured to the patient's breast. In some variations, the thread does nothave to be secured to breast. In some examples, the thread may eliminatetransection concern while providing heat resistance and optimal strengthduring surgery. The thread may be flexible or non-rigid such that it mayprevent the hook body from unintentionally moving or being driven pastthe target tissue. In a variation, the thread 104 may be flexible yetstrong. For example, the thread 104 can be flexible such that it canbend when outside the body and therefore not be at risk of being movedinside the body if touched or bumped outside the body of the patient.The thread 104 can be heat resistant such that it is not at risk ofbeing severed if near a cauterizer and can be tough enough to not be atrisk of being cut by a scalpel. Non-limiting examples of the materialthat may make up the thread include chromium cobalt, stainless steel,nitinol, and Kevlar. In a variation, the thread 104 is a metal thread.In one variation, the thread is made of chromium cobalt or acobalt-chrome alloy. In another variation, the thread is made ofnitinol.

The thread 104 may be located within the lumen of the stylet 108, thelumen of the needle 106, and/or through the handle body/plunger when thehook assembly 105 is loaded within the handle assembly 110 prior todeployment. The thread 104 may have a length of at least the length ofthe needle 106. In a variation, the thread 104 has a length so that itextends out of the second ends of the needle 106 and stylet 108respectively. The thread 104 may have a length that is sufficient toextend through the breast and extend outside the body of the patient. Ina variation, the thread 104 has a length of at least 5 cm. In avariation, the thread 104 has a length of at least 8 cm. In a variation,the thread 104 has a length of at least 10 cm. In a variation, thethread 104 has a length of at least 12 cm. In a variation, the thread104 has a length of at least 14 cm. In a variation, the thread 104 has alength of at least 16 cm. In a variation, the thread 104 has a length ofat least 20 cm. The thread 104 may have a diameter sufficient to fitthrough the lumen of the stylet 108 which is in the lumen of the needle106. In a variation, the thread 104 may have a diameter of less than 1mm. In a variation, the thread 104 may have a diameter of less than 0.5mm. In a variation, the thread 104 may have a diameter of less than 0.25mm.

Different variations of the hook assembly 105 may include differentlengths of thread 104. For example, the tissue marking device 100 may besized to the patient. In some variations, the excess thread 104 may beattached to the patient. For example, excess thread 104 may be wound andattached to the skin of the patient with an adhesive.

In a variation, the thread 104 may further include one or moreradiopaque markers. In some variations, the radiopaque marker may be aband, a ball, or a knot in the thread 104. In some variations, theradiopaque marker may be at the point the thread 104 connects to thehook body 102. In other variations, the radiopaque marker may be at apoint along the length of the thread 104. For example, a radiopaquemarker may be located both at the hook body 102 and on the thread 104about 0.5 to 2 cm away from the connection point to the hook body 102,depending on the length of the hook body in the compressedconfiguration.

In other variations, the thread 104 may include a series of marker bands118 along a length of the thread, as seen for example in FIG. 3F. Themarker bands may be raised from the thread such that a surgeon may beable to physically feel the marker bands. In addition, the marker bandsmay provide a surface to push against the hook body and/or other markerbands when the hook body is pushed out of the needle by the stylet. Forexample, the distal most marker band may push the hook body without anyslack in between with the thread and the series of marker bands may beas close together as needed so they are all pushing on each other withno slack in the thread. In some variations, the marker bands 118 may beplaced such that the distal most marker band is a set distance from theproximal end of the hook body 102 when in the compressed configuration.For example, the marker bands 118 may be placed such that the distalmost marker band is about 0.5 mm, 1 mm, 2 mm, or 3 mm from the proximalend of the hook body 102 when in the compressed configuration. In othervariations, the marker bands 118 may be placed on the thread 104 suchthat the distal most marker band is a set distance from where the threadconnects to the hook body 102 (i.e. the center of the hook body). Forexample, the marker bands 118 may be placed on the thread 104 such thatthe distal most marker band is 0.5 cm to 2 cm from where the threadconnects to the hook body 102 (i.e. the center of the hook body),depending on the length of the hook body in the compressedconfiguration. In at least one example, the marker bands 118 are placedon the thread 104 such that the distal most marker band is 1 cm fromwhere the thread connects to the hook body 102.

In a variation, the thread may include 1 marker band. In a variation,the thread may include at least 2 marker bands. In a variation, thethread may include at least 3 marker bands. In a variation, the threadmay include at least 4 marker bands. In a variation, the thread mayinclude at least 5 marker bands. In a variation, the thread may includeat least 6 marker bands. The marker bands 118 may be separated from eachother by a set distance. For example, each marker band may be separatedby 0.5 mm, 1 mm, 2 mm, or 3 mm. It will be appreciated that theradiopaque markers are configured to communicate a set distance tofurther facilitate the measurement of target tissue, to distinguishbetween multiple marked tissues, to demonstrate the distance of the hookfrom the targeted lesion, or to indicate a distance from the hook bodyto a biopsy marker clip. It will be appreciated that any arrangement ofradiopaque markers is contemplated.

The tissue marking device 100 may further include a handle assembly 110.As seen in FIG. 1 and FIGS. 4A-4E, the handle assembly 110 includes ahandle body 111, a plunger 112, a needle 106, and a stylet 108. As seenin FIGS. 4A-4C, the handle body 111 may include a grip 116 at the distalend of the handle body 111, a hollow longitudinal barrel, and a guide115 extending longitudinally along a length of the handle body 111. Theplunger 112 is operable to fit within the barrel of the handle body 111and includes a locking mechanism 114 at its distal end operable to fitwithin the guide 115. The hook assembly 105 is initially containedwithin the needle 106 of the handle assembly 110 until it is deployed bythe handle assembly 110 once near the target tissue. The handle assembly110, by way of the needle 106, is configured to enter the breast andplace the hook assembly 105 in the target tissue.

The needle 106 has a lumen that is open on a first end and a second end.In a variation, the needle 106 is a 16 gauge needle. In a variation, theneedle 106 is a 17 gauge needle. In a variation, the needle 106 is an 18gauge needle. In a variation, the needle 106 is a 19 gauge needle. In avariation, the needle 106 is a 20 gauge needle. In a variation, theneedle 106 is at least 5 cm long. In a variation, the needle 106 is atleast 7 cm long. In a variation, the needle 106 is at least 8 cm long.In a variation, the needle 106 is at least 10 cm long. In a variation,the needle 106 is at least 12 cm long. In a variation, the needle 106 isat least 14 cm long. In a variation, the needle 106 is at least 16 cmlong. In a variation, the needle 106 is at least 20 cm long. In avariation, the needle 106 is less than 20 cm long. The needle 106 isattached to the distal end of the handle body 111. The needle 106 may bereversibly or irreversibly attached to the distal end of the handle body111.

The stylet 108 may be a tube that is open on a first end and second end.The stylet 108 is configured to sit within the needle 106 and hold thethread 104 within its lumen. The first end of the stylet 108 may extendinto the handle body 111 and the second end of the stylet 108 may reston or near the proximal end of the hook body 102. FIGS. 2A and 2B showthe second end of the stylet 108 surrounding the thread 104 and near theproximal end of the hook body 102. In a variation, the first end of thestylet 108 is connected to the distal end of the plunger 112.

The stylet 108 may have a diameter sufficient to fit within the lumen ofthe needle 106 while being the same diameter or smaller than thediameter of the hook body 102. This allows for the stylet 108 to push onthe proximal end of the hook body 102 to push the hook body 102 out ofthe needle and into the target tissue. In a variation, the stylet 108may have an outer diameter less than the diameter of the lumen of theneedle 106. In a variation, the stylet 108 may have an outer diameter ofless than 1.5 mm. In a variation, the stylet 108 may have an outerdiameter of less than 1 mm. In a variation, the stylet 108 may have anouter diameter of less than 0.75 mm. In a variation, the stylet 108 mayhave an outer diameter of less than 0.5 mm. In a variation, the stylet108 may have an outer diameter of at least 0.5 mm. In a variation, lumenof the stylet 108 may have a diameter of at least 0.25 mm. In avariation, lumen of the stylet 108 may have a diameter of less than 0.5mm. In a variation, lumen of the stylet 108 may have a diameter of lessthan 0.75 mm. In a variation, lumen of the stylet 108 may have adiameter of less than 1 mm.

The stylet 108 may have a length that is at least the length of theneedle 106. In a variation, the stylet 108 is longer than the needle106. In a variation, the stylet 108 is at least 5 cm long. In avariation, the stylet 108 is at least 7 cm long. In a variation, thestylet 108 is at least 8 cm long. In a variation, the stylet 108 is atleast 10 cm long. In a variation, the stylet 108 is at least 12 cm long.In a variation, the stylet 108 is at least 14 cm long. In a variation,the stylet 108 is at least 16 cm long. In a variation, the stylet 108 isat least 20 cm long. In a variation, the stylet 108 is less than 20 cmlong.

The handle body is designed to minimize size and weight of the device.It has an ergonomic grip and the hook assembly can be deployed with asimple turn of the handle. As seen in FIG. 4C, the handle body 111includes a grip 116 at the distal end of the handle body 111, a hollowlongitudinal barrel, and a guide 115 extending longitudinally along alength of the handle body 111. The handle body may be made of moldedplastic in one variation.

As seen in FIG. 4D, the plunger 112 includes a locking mechanism 114 atits distal end operable to fit within the guide 115 of the handle body111. As seen in FIG. 4E, the plunger 112 is sized to fit inside thebarrel of the handle body 111. The plunger 112 extends the length of thehandle body 111, protrudes out the proximal end of the handle body 111,and connects to the stylet 108 at its distal end within the handle body111. The plunger 112 is configured to actuate between two distinctpositions, an extended position and a depressed position. FIG. 4A showsthe plunger 112 in the extended position when the handle assembly 110 isloaded with the hook assembly 105. In particular, FIG. 4A shows thethread 104 loaded through the handle body 111 and plunger 112. When theplunger 112 is in the extended position, the hook body 102 remains inthe needle 106 and the thread remains in the stylet 108, needle 106, andhook body 111/plunger 112. FIG. 4B shows the plunger 112 in thedepressed position when the hook assembly 105 has been deployed. Whenthe plunger 112 is pushed from the extended position to the depressedposition, the hook body 102 is pushed by the stylet 108 the distance theplunger 112 is pressed, and therefore, the hook body 102 extends pastthe second end of the needle 106 by the same distance. Therefore, whenplacing the needle 106 in the target tissue, it is known what distancethe hook body 102 will be pushed past the second end of the needle 106when the plunger 112 is depressed and the hook body 102 is deployed.

The handle body 111 may further include an opening for receiving aproximal end of the thread. In one variation, the plunger may furtherinclude an opening 118, as seen in FIG. 4A, that receives the excess endof the thread 104. In other variations, the opening 118 may be locatedon any portion of the handle body 111 and/or the plunger 112.

The handle body 111 or the plunger 112 may further include a lockingmechanism 114. In a variation, the locking mechanism 114 is near thedistal end of the plunger 112. The locking mechanism 114 may be aprotrusion that fits within the guide 115 extending at least a portionof the length of the handle body 111. The locking mechanism 114 may bein a locked or unlocked position. When in the locked position, thelocking mechanism 114 may be located within a recession 113 on thehandle body 111 perpendicular to the guide 115 at the proximal end ofthe guide 115. To move the locking mechanism 114 to the unlockedposition, the locking mechanism 114 is moved or rotated to be outside ofthe recession 113 to be within the guide 115. Because the lockingmechanism is on the plunger, the plunger is moved or rotated such thatthe locking mechanism is outside the recession and within the guide tounlock the handle. In some variations, the recession has a length atleast half the circumference of the handle body such that the plungerhas to rotate at least 180° to unlock. The locking mechanism 114 may beconnected to the plunger 112 such that the locking mechanism 114prevents the actuation of the plunger 112 when the locking mechanism 114is in the locked position. FIG. 4A shows the locking mechanism in alocked position. FIG. 4B shows the locking mechanism in an unlockedposition. The length of the guide 115 may be compatible with the lengthof the plunger 112 and the desired distance that the plunger may bepushed to deploy the hook assembly 105.

The locking mechanism 114 prevents the hook assembly 105 from beingaccidentally deployed during assembly, shipment, and insertion of theneedle. Because the tissue marking device 100 is a single use,non-removable device, the locking mechanism 114 is necessary to preventaccidental deployment until it is confirmed that the hook assembly willbe deployed in the desired location of the target tissue.

In a variation, the handle body 111 may further include a grip 116. In avariation, the grip 116 may be a two finger grip for easy manipulationby the physician, as seen in FIGS. 4A-4C. Further, the handle body 111may be lightweight, such that the weight of the handle body attached tothe needle 106 does not affect the movement or placement of the hookassembly 105.

In use, the hook assembly 105 is seated in the second end of the needle106 and stylet 108 such that the hooks 101 and retention mechanism 107are in the compressed configuration. The handle assembly 110, by way ofthe needle 106, is forced in the breast until the second end of theneedle 106 reaches the target tissue. The locking mechanism 114 isrotated from the recession 113 into the guide 115 to be in the unlockedposition. The plunger 112 is pressed by the thumb or another finger ofthe user. The first end of the stylet 108 is then pressed by the plunger112 causing the hook body 102 to extend past the second end of theneedle 106, open/deploy the hooks 101, and embed in the target tissue.The needle 106 and stylet 108 are removed from the tissue using thehandle body 111, leaving the thread 104 protruding from the skin andattached to the hook body 102.

A description of a method for marking tissue for removal using a tissuemarking device, as illustrated in FIG. 5 , is disclosed herein. Themethod shown in FIG. 5 is provided by way of example, as there are avariety of ways to carry out the method. Additionally, while the examplemethods are illustrated with a particular order of blocks, those ofordinary skill in the art will appreciate that FIG. 5 and the blocksshown therein can be executed in any order that accomplishes thetechnical advantages of the present disclosure and can include fewer ormore blocks than illustrated. Each block shown in FIG. 5 represents oneor more processes, methods or subroutines, carried out in the examplemethod.

Referring now to FIG. 5 , the method of using the tissue marking device100 is depicted in one variation. Method 200 includes inserting theneedle with the compressed hook assembly in a patient so that the hookbody is near a target tissue at steps 204 and 206, unlocking the lockingmechanism at step 208, depressing the plunger to extend the hook bodypast the needle and embed in the target tissue at step 210, and removingthe needle and stylet from the patient at step 212. In a variation, themethod 200 may further include leaving the thread exposed on the surfaceof the skin. The exposed thread may then be secured to the skin. In somevariations, the method may further include loading the hook assembly inthe handle assembly prior to inserting the needle into the patient.Loading the hook assemble in the handle assembly may includeloading/inserting the hook body into the needle and loading/insertingthe thread through the stylet, needle, and plunger within the handlebody. The hooks and retention mechanism of the hook body may need to bephysically compressed to be loaded within the needle.

The use of the tissue marking device allows for the safe separation oftreatment days. The separation of treatment days provides time for thehook assembly to be properly placed and then patient can return on adifferent day for surgery instead of being rushed to surgery on the sameday and being severely restricted on movement for fear of the markermigrating. In addition, the separation of treatment days overcomes theinefficiencies created trying to coordinate radiology, surgery,operating room, and patient physical location when the localization andsurgery are on the same day.

In another variation, FIG. 6 provides a method for marking tissue forremoval using a tissue marking device. The method shown in FIG. 6 isprovided by way of example, as there are a variety of ways to carry outthe method. Additionally, while the example methods are illustrated witha particular order of blocks, those of ordinary skill in the art willappreciate that FIG. 6 and the blocks shown therein can be executed inany order that accomplishes the technical advantages of the presentdisclosure and can include fewer or more blocks than illustrated. Eachblock shown in FIG. 6 represents one or more processes, methods orsubroutines, carried out in the example method.

Referring now to FIG. 6 , the method of implanting and removing the hookassembly 105 of the tissue marking device 100 is depicted in onevariation. Method 300 includes implanting the hook assembly of thetissue marking device into a target tissue of a patient at step 302 andremoving the hook assembly and target tissue on a separate day fromimplantation at step 304. In a variation, the hook assembly is operableto absorb compression forces without migrating within the target tissuesuch that re-localization/re-implantation would be required. In avariation, the hook assembly is operable to allow the patient to havesurgery to remove the hook assembly on a separate day fromlocalization/implantation. The ability to absorb compression forces maypermit the patient to participate in normal activity between the time oflocalization/implantation of the hook assembly and the time of surgeryto remove the target tissue. Non-limiting examples of normal activityinclude sleeping (face down if desired), sexual activity, taking care ofloved ones (for example, kids), exercising, and/or lifting heavingobjects.

Unlike conventional wire marker devices, the hook assembly can beembedded in a target tissue and still allow a patient to perform mostnormal activities. This allows the hook assembly to be placed far inadvance of the surgery. The structure of the hook body with hooks andretention mechanism may allow for the hook assembly to flex with thepatient's movements and thus not migrate within the target tissue. In avariation, the hook body may only migrate up to 15 mm from its originalplacement location. In a variation, the hook body may only migrate up to10 mm from its original placement location. In a variation, the hookbody may only migrate up to 8 mm from its original placement location.In a variation, the hook body may only migrate up to 6 mm from itsoriginal placement location. In a variation, the hook body may onlymigrate up to 5 mm from its original placement location. In a variation,the hook body may only migrate up to 4 mm from its original placementlocation. In a variation, the hook body may only migrate up to 2 mm fromits original placement location. In a variation, the hook body may onlymigrate up to 1 mm from its original placement location. In a variation,the hook body may only migrate up to 0.5 mm from its original placementlocation. In addition, the thread may further allow for the patient'smovements to not affect the hook body placement. The flexible thread mayimpart less tension on the hook body as compared to a standard wire suchthat it flexes instead of pulling on the hook body. In some variations,the hook assembly may have a pull force of greater than 380 g.

In some variations, the method may further include surgically removingthe hook assembly and target tissue on a separate day from when the hookassembly was implanted. In a variation, the hook assembly may be placedup to 24 hours before surgery. In a variation, the hook assembly may beplaced more than 24 hours before surgery. In a variation, the hookassembly may be placed up to 2 days before surgery. In a variation, thehook assembly may be placed up to 5 days before surgery. In a variation,the hook assembly may be placed up to 8 days before surgery. In avariation, the hook assembly may be placed up to 10 days before surgery.In a variation, the hook assembly may be placed up to 12 days beforesurgery. In a variation, the hook assembly may be removed at least 24hours after implantation. In a variation, the hook assembly may beremoved up to 2 days after implantation. In a variation, the hookassembly may be removed up to 5 days after implantation. In a variation,the hook assembly may be removed up to 8 days after implantation. In avariation, the hook assembly may be removed up to 10 days afterimplantation. In a variation, the hook assembly may be removed up to 12days after implantation.

A tissue marking device comprising: a hook assembly having a compressedconfiguration and a deployed configuration, the hook assemblycomprising: a hook body comprising at least two hooks; and a threadconnected to the hook body; and a handle assembly for positioning thehook assembly in a targeted tissue comprising: a handle body having aproximal end and a distal end; a needle having a lumen with an openfirst end and a second end; and a stylet having a lumen with an openfirst end and a second end, wherein the hook body and the stylet arewithin the lumen of the needle and the thread is within the lumen of thestylet when the hook assembly is in the compressed configuration.

A tissue marking device comprising: a hook body having a proximal endand a distal end, the hook body comprising at least two hooks, whereinthe hook body has a compressed configuration and a deployedconfiguration.

A tissue marking device comprising: a hook body comprising at least twohooks; a metal thread crimped or welded to the proximal end of the hookbody.

A tissue marking device comprising: a handle assembly comprising: ahandle body having a proximal end and a distal end; a needle having alumen with an open first end and a second end, the needle lumenconfigured to contain a hook body in a compressed configuration; and astylet having a lumen with an open first end and a second end, thestylet configured to be within the lumen of the needle and the styletlumen configured to contain a thread connected to the hook body.

The handle body comprises a plunger and a locking mechanism. The firstend of the stylet is connected to the plunger such that pressing theplunger extends the hook body into the target tissue. The handle bodyfurther comprises a recession and guide for positioning the lockingmechanism in a locked and unlocked position, respectively. The hook bodycomprises two hooks. The hook body comprises three hooks. The tissuehook body comprises at least two hooks separated by 180°, 120°, 90°,45°, or a combination thereof. The hook body comprises at least twohooks having a straight configuration or curved configuration. The hookbody comprises a laser cut nitinol tube. The thread is selected from achromium cobalt, stainless steel, nitinol, or Kevlar thread. The threadis crimped or welded to a proximal end of the hook body. The hook bodyhas at least one radiopaque marker. The thread has at least oneradiopaque marker. The first end of the needle is connected to thedistal end of the handle body.

A method of marking a target tissue in a patient comprising: inserting atissue marking device into a patient, the tissue marking devicecomprising: a hook assembly comprising a hook body with at least twohooks and a thread; and a handle assembly comprising a stylet, a needle,and a handle body comprising a locking mechanism and a plunger;confirming the location of the needle such that the hook body is nearthe target tissue; unlocking the locking mechanism on the handle body;depressing the plunger to extend the hook body past the needle and openthe at least two hooks to embed the hook body in the target tissue; andremoving the needle and the stylet from the patient.

The method further comprises loading the hook assembly into the handleassembly. The method further comprises securing the thread to thepatient's skin. The method further comprises having the patient returnat least 24 hours later for surgery. The patient returns up to 12 dayslater for surgery. The hook assembly has a compressed configuration anda deployed configuration. The hook body and the stylet are within thelumen of the needle and the thread is within the lumen of the styletwhen the hook assembly is in the compressed configuration. The handlebody further comprises a recession and guide for positioning the lockingmechanism in a locked and unlocked position, respectively. The hook bodycomprises two hooks. The hook body comprises three hooks. The hook bodycomprises at least two hooks separated by 180°, 120°, 90°, 45°, or acombination thereof. The hook body comprises at least two hooks having astraight configuration or curved configuration. The hook body comprisesa laser cut nitinol tube. The thread is selected from a chromium cobalt,stainless steel, nitinol, or Kevlar thread. The thread is crimped orwelded to a proximal end of the hook body. The hook body has at leastone radiopaque marker. The thread has at least one radiopaque marker.The target tissue is within the patient's breast.

EXAMPLES Example 1 Pull Force Testing

Resistance capability towards traction force of the tissue markingdevice was examined. Turkey breast was used as a substitute for softerhuman breast tissue. Tissues were examined at room temperature. Thetissues were compressed in a mammography unit using a compression forceof 10 N. Four tissue marking devices (DFC “H” Hook) with a four armconfiguration (two distal hooks and two proximal hooks) were insertedabout 5 cm into the compressed tissues. Traction force was applied ineach case for 1 second using an analogue Spring Scale starting with 50 gof pulling force (1000 g=9.81 Newton). Pulling force was increased insteps of 50 g. Table 1 below shows the pulling force observed to pullthe device out of the tissue.

TABLE 1 DFC Hook Testing rev.O2 Sample # Hook Description Pull Force(Grams) 2 DFC (Nitinol-“H” Hook-rev.O2) 391.86 3 DFC (Nitinol-“H”Hook-rev.O2) 385.68 4 DFC (Nitinol-“H” Hook-rev.O2) 380.42 5 DFC(Nitinol-“H” Hook-rev.O2) 415.12 * Average Pull Force 393.27 StandardDeviation 15.30

In general, the pull forces measured with the tissue marking devicestracked with or were greater than the localization devices currentlyavailable (see Kaul, et al., Dislocability of Localization Devices forNonpalpable Breast Lesions: Experimental Results, Radiology Research andPractice, 2014).

Example 2 Compression Testing

To test any migration of the hook assembly in response to compressionforces, a 3D printed test system with a motor and an electric cyclecounter was created to hold and compress a breast equivalent gel. A hookbody with a four arm configuration (two distal hooks and two proximalhooks) was injected into 1 inch of breast equivalent gel and pre andpost compression measurements were taken with a caliper. The gel withthe implanted hook body was compressed by 30% for each compression. Aset of 100 compressions was performed and then a set of 1,000compressions was performed to generally simulate normal activity for apatient. For each set, the hook body was assessed for movement from theposition of the hook body before testing. Table 2 shows the movementobserved before and after compressions.

TABLE 2 Position of Hook before Position of Hook after Number of CyclesTesting Testing 100 9.55 mm 9.56 mm 1000 9.56 mm 9.59 mm

The four arm hook body only migrated 0.01 mm after 100 compressioncycles and 0.03 mm after 1000 compression cycles. Therefore, the fourarm hook demonstrated minimal migration such that it may absorbcompressions encountered in normal activity between the time of placingthe hook assembly and surgery to remove the hook assembly and targettissue.

The particular variations disclosed above are illustrative only, as thevariations may be modified and practiced in different but equivalentmanners apparent to those skilled in the art having the benefit of theteachings herein. It is therefore evident that the particular variationsdisclosed above may be altered or modified, and all such variations areconsidered within the scope and spirit of the application. Accordingly,the protection sought herein is as set forth in the description.Although the present variations are shown above, they are not limited tojust these variations, but are amenable to various changes andmodifications without departing from the spirit thereof. Additionally, anumber of well-known processes and elements have not been described inorder to avoid unnecessarily obscuring the present invention.Accordingly, the above description should not be taken as limiting thescope of the invention.

Those skilled in the art will appreciate that the presently disclosedvariations teach by way of example and not by limitation. Therefore, thematter contained in the above description or shown in the accompanyingdrawings should be interpreted as illustrative and not in a limitingsense. The following claims are intended to cover all generic andspecific features described herein, as well as all statements of thescope of the present method and system, which, as a matter of language,might be said to fall therebetween.

What is claimed is:
 1. A tissue marking device, comprising: a hookassembly, comprising: a hook body having a proximal end and a distalend, the hook body comprising at least two distal hooks at the distalend and a retention mechanism comprising at least two proximal hooks atthe proximal end; and a flexible thread bonded to the proximal end ofthe hook body, the thread comprising at least one radiopaque markerraised from the thread; and a handle assembly operable for positioningthe hook assembly in a targeted tissue, the handle assembly comprising:a handle body having a proximal end and a distal end; a needle having alumen with an open first end and a second end; and a stylet having alumen with an open first end and a second end, wherein the hook body hasa compressed configuration and a deployed configuration, wherein each ofthe at least two distal hooks and each of the at least two proximalhooks of the retention mechanism form an H configuration when the hookbody is in the deployed configuration, wherein the thread is within thelumen of the stylet when the hook body is in the compressedconfiguration, wherein the hook body and the stylet are aligned with acentral axis of the needle and within the lumen of the needle when thehook body is in the compressed configuration, and wherein the hook bodyand the stylet are aligned with the central axis of the needle when thehook body is in the deployed configuration.
 2. The tissue marking deviceof claim 1, wherein the handle assembly further comprises a plunger witha locking mechanism positionable in a locked position and an unlockedposition, the locking mechanism configured to (a) prevent actuation ofthe plunger in the locked position to prevent accidental deployment ofthe hook assembly and (b) permit actuation of the plunger in theunlocked position to deploy the hook assembly.
 3. The tissue markingdevice of claim 2, wherein the first end of the stylet is connected tothe plunger such that pressing the plunger extends the hook body intothe targeted tissue.
 4. The tissue marking device of claim 2, whereinthe handle body further comprises a recession and a guide forselectively positioning the locking mechanism in the locked position andthe unlocked position, respectively.
 5. The tissue marking device ofclaim 1, wherein the hook body is formed from a laser cut nitinol tube.6. The tissue marking device of claim 1, wherein the thread is formedfrom a material selected from the group consisting of chromium cobalt,stainless steel, nitinol, or Kevlar.
 7. The tissue marking device ofclaim 1, wherein the distal end of the hook body includes a pointeddistal end extending past the at least two distal hooks.
 8. The tissuemarking device of claim 1, wherein the hook body comprises at least oneradiopaque marker.
 9. The tissue marking device of claim 1, wherein theat least one radiopaque marker is a radiopaque marker band configured toprovide a surface to push against the hook body when the hook body ispushed out of the needle by the stylet.
 10. The tissue marking device ofclaim 1, wherein the at least one radiopaque marker comprises aplurality of radiopaque marker bands spaced a set distance apart fromone another.
 11. The tissue marking device of claim 10, wherein a distalmost one of the plurality of radiopaque marker bands is a first setdistance from a center of the hook body and a second set distance fromthe proximal end of the hook body when the hook body is in thecompressed configuration.
 12. The tissue marking device of claim 1,wherein the first end of the needle is connected to the distal end ofthe handle body.
 13. A method of marking a targeted tissue in a patient,the method comprising: implanting the hook assembly of the tissuemarking device of claim 1 into the targeted tissue of the patient,wherein the hook assembly is operable to absorb compression withoutmigrating more than 1 cm within the targeted tissue.
 14. The method ofclaim 13, wherein the hook assembly does not migrate more than 5 mmwithin the targeted tissue when implanted for more than 24 hours. 15.The method of claim 13, further comprising performing a surgery on thepatient, the surgery comprising removing the hook assembly and thetargeted tissue on a separate day from a day on which the hook assemblywas implanted.
 16. The method of claim 15, wherein the removing step isperformed at least 24 hours after the implanting step.
 17. The method ofclaim 15, further comprising allowing the patient to participate innormal activity between the implanting step and the removing step. 18.The method of claim 17, wherein the normal activity is selected from thegroup consisting of sleeping, sexual activity, taking care of lovedones, exercising, and lifting heaving objects.
 19. The method of claim13, wherein the targeted tissue is within the patient's breast.
 20. Amethod of marking a targeted tissue in a patient, the method comprising:inserting the tissue marking device of claim 2 into the patient;confirming a location of the needle such that the hook body is near thetargeted tissue; positioning the locking mechanism in the unlockedposition; depressing the plunger to extend the hook body past the needleand open the at least two distal hooks and the at least two proximalhooks of the retention mechanism to embed the hook body in the targetedtissue; and removing the needle and the stylet from the patient.